impact of magnetic resonance and biomarkers for screening for prostate cancer. cost-effectiveness analysis

Conditions: Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification; Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique; Establish the Efficacy Between the Four Schemes in Terms of the Patient's Subjective Perception Regarding Pain and Quality of Life; Establish the Association of the Tumor Biomarker in the Early Detection and Aggressiveness of Tumors; Establish the Possible Interaction Between Biomarkers and Resonance in Different Prostate Biopsy Models to Define Tumor Presence and / or Tumor Aggressiveness; Establish the Possible Relationship Between the Expression Profiles of the microRNAs; Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI

Summary: objectives: to establish if there are differences between an ultrasound-guided transrectal prostate biopsy (bpte) and a transperineal prostatic biopsy (bptp) with and without a multiparametric magnetic resonance (rmmp) in patients with clinical suspicion of prostate cancer (pc) to first prostatic biopsy in terms of: 1. rate of detection and diagnosis of prostate cancer. 2. aggressiveness of the detected tumors. 3. association of the marker \[-2\] propsa and the prostate cancer health index (phi) and micrornas for the diagnosis of tumors. 4. adverse effects of the intervention and subjective perception of the patient: pain and degree of satisfaction, and impairment of quality of life. 5. cost-effectiveness analysis of the different intervention options. study design: randomized, single-blind prospective clinical study to compare four schemes: rmmp + bpte vs. bpte 12 cylinders vs rmmp + bptp vs bptp 12 cylinders. study population: patients with clinical suspicion of prostate cancer with psa between 3-20 ng / ml and normal or abnormal rectal examination, candidates for a first prostate biopsy. research techniques: bpte standard of 12 cylinders compared to rmmp previous to bpte vs bptp of 12 cylinders compared to bptp with previous rmmp.


Eligibility criteria:
inclusion criteria: * signature of informed consent prior to performing any of the specific procedures of the study * age between 50 \* - 75 years (\* 45 years, if family history) * patients with clinical suspicion of prostate cancer * indication of a first biopsy during the study period. * life expectancy greater than 10 years. exclusion criteria: * patients previously randomized in the present study. * patients submitted prior to a prostate biopsy. * patients with a previous diagnosis of prostate cancer and / or previous prostate surgery. * patients with a previous episode of acute prostatitis of infectious origin in the 3 months prior to inclusion in the study. * patients with an active urinary tract infection and / or any previous pathology of severity in the 3 months prior to inclusion. * impossibility of performing transrectal or transperineal biopsy and / or magnetic resonance. * patients who have received hormonal treatment prior to androgen blockade in the 6 months prior to inclusion in the study. * history of other tumors.

Keywords: prostate cancer biomarkers psa mmpm quality of life